The drama around the approval of Biogen’s controversial Alzheimer’s treatment continued this week. After the FDA gave the drug, Aduhelm (aducanumab) the green light, two members of the agency’s advisory panel quit in protest over the decision.
One of the members, David S. Knopman, a neurologist at the Mayo Clinic, told The Washington Post that he didn’t want to be a part of a “sham process” that would result in drugs like aducanumab being approved.
The other member, who is a neurologist at Washington University, told Stat News that he was leaving the advisory panel because the FDA did not consult further with the advisory committee before rendering its verdict earlier this week.
Criticisms of the FDA’s handling of aducanumab began after the advisory committee voted resoundingly against the drug’s approval last November. During the ad comm meeting, the panel blasted the FDA for co-authoring a pre-meeting briefing document with Biogen and said that the drug did not appear to be effective enough to warrant approval.
The FDA, which is not required to follow the advice of its advisory panels, then took its time weighing an approval of aducanumab — even pushing its decision date from March to June and saying that it had new data from Biogen to consider. Some analysts speculated that the delay would allow the FDA to say that it had reviewed data that the ad comm panel did not see and approve the drug against the panel’s advice.
Yet, in his resignation letter to the FDA, Knopman said that it was clear from the get-go that the agency intended on approving aducanumab.
“The whole saga of the approval of aducanumab … made a mockery of the [advisory] committee’s consultative process. While I realize that the committee is advisory, the approval of aducanumab appears [to] have been foreordained,” he said in an email to the agency.
